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A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD), MAESTRO-NAFLD-Open-Label-Extension (MAESTRO-NAFLD-OLE)

StatusActive, Not Recruiting
PhasePhase 3
Started2021-07-09
View on ClinicalTrials.gov ↗

Amendment history

2026-05-22
Study Status, Study Design, Arms and Interventions, Contacts/Locations v5
Primary completion date2026-03→2027-03
Completion date2026-04→2027-04
Enrollment targetestimated 1000→confirmed 810
Study sites71→76
2025-07-30
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v4
Trial statusRecruiting→Active, Not Recruiting
Study sites74→71
2023-11-28
Study Identification, Study Status, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v3
Primary completion date2024-04→2026-03
Completion date2024-04→2026-04
Study sites70→74
Study arms3→6
Eligibility criteria+646 characters
Inclusion Criteria: MustFor havepatients participatedwho incompleted MAESTRO-NAFLD-1, completed the Week 52 visit, and completed [...] he Extension Day 1 visit, and are willing to participate in the Extension studyMAESTRO-NAFLD-OLE and provide written informed consent. MustFor patients who screen failed MAESTRO-NASH, must provide written informed consent for MAESTRO-NAFLD-OLE and [...] results: NAS = 3, steatosis 1, ballooning 1, inflammation 1, withOR F2 or F3 NAS = 3, ballooning 0, with F1B, F2 or F3 NAS ≥ 4, at least 1 in all NAS components, F1A or F1C, PRO-C3 ≤ 14 (NASH, but ineligible for MAESTRO-NAS [...] [...]
Primary endpoints1 entry, revised
The effect of once daily, oral administration of 80 or 100 mg resmetirom versus placebo on the incidence of adverse events.
2022-10-18
Study Status v2
Primary completion date2022-12→2024-04
Completion date2022-12→2024-04
2021-08-12
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-07→confirmed 2021-07-09
Study sitesdetails revised at 70 of 70 sites
2021-07-02
Original filing
A 52-Week, Multi-center, Open-label, Active Treatment Extension Study to Evaluate Safety and Tolerability of Once Daily, Oral Administration of Resmetirom (MGL-3196)
Trial Details
NCT Number NCT04951219
Lead Sponsor Madrigal Pharmaceuticals, Inc.
Conditions Non-Alcoholic Fatty Liver Disease
Enrollment 810 participants
Start Date 2021-07-09
Primary Completion 2027-03 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2026-05-27